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Multicenter Study
. 2025 Sep 15:19:8295-8308.
doi: 10.2147/DDDT.S506108. eCollection 2025.

Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT)

Xiliang Zhao  1 , Guojie Cheng  2 , Liling Sun  3 , Yajuan Liu  4 , Xin Du  1 , Su'e Xu  5 , Litao Wu  6 , Ying Wei  7 , Wei Liu  8 , Lifu Miao  9 , Qihua Zhang  4 , Changsheng Ma  1 , Yong Zeng  1
Affiliations
Multicenter Study

Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT)

Xiliang Zhao et al. Drug Des Devel Ther. .

Abstract

Purpose: Coronary artery disease represents a major clinical burden, and angina pectoris is the most frequent manifestation of coronary artery disease. Nicorandil is commonly used for the management of angina pectoris; however, its effects on health status outcomes are unclear.

Patients and methods: This multicenter, prospective, cohort study (GREAT) enrolled 1556 adult coronary artery disease patients with angina pectoris from nine hospitals in China. Patients were classified into nicorandil and control groups. The primary outcome was the change in the Seattle Angina Questionnaire summary score (SAQ-SS) from baseline to 12 months. Secondary outcomes included changes in SAQ-SS at 3, 6, and 9 months. Propensity score matching (PSM) was used to reduce bias and control for confounding factors.

Results: We analyzed 1528 patients with baseline and 12-month health status data. After PSM, 450 matched pairs of patients were identified. A difference of ≥5 points for SAQ-SS is considered clinically significant. Patients in the nicorandil group reported greater mean improvement in SAQ-SS (17.6 ± 14.0, difference: 2.50, 95% CI: 0.74-4.27; P=0.003) at 12 months compared with the control group (15.1 ± 13.0; P=0.003). Similar trends were noted in SAQ-SS at 3, 6, and 9 months. Additionally, nicorandil users exhibited significantly greater improvements in the SAQ physical limitation (11.7 ± 16.9 vs 8.4 ± 16.9; difference: 3.27, 95% CI, 1.05-5.48; P =0.001) and SAQ-QoL domain (18.9 ± 21.4 vs 16.3 ± 20.4; difference: 2.62, 95% CI, -0.12 to 5.35; P=0.042) at 12 months. Most patients in the entire cohort (78.4%) reported a clinical improvement in SAQ-SS. The nicorandil group had a higher proportion of patients with at least large improvements (≥20 points) in SAQ-SS (42.5% vs 32.9%; difference: 9.7%, 95% CI: 3.3-16.0; P= 0.004).

Conclusion: Among patients with angina pectoris, anti-angina treatment improved the majority of patients' health status. Nicorandil-based regimens were associated with a greater health status outcome improvement compared to those not using nicorandil in coronary artery disease patients with angina pectoris. A substantial proportion of patients using nicorandil exhibited noteworthy improvements in health status outcomes at one year.

Registration: ClinicalTrials.gov, NCT05050773.

Keywords: Seattle angina questionnaire; angina pectoris; coronary artery disease; health-related outcomes; nicorandil; real-world.

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Conflict of interest statement

The authors have no competing interests to declare that are relevant to the content of this article.

Figures

Figure 1
Figure 1
Patient Flow Diagram. *Patients without any follow-up visit were excluded from full analysis set.
Figure 2
Figure 2
SAQ-SS Changes from Baseline to 12 Months Display with Sankey Flow Diagrams (post-PSM). SAQ-SS categories were defined as: 0–24 (from very poor to poor health), 25–49 (poor to fair), 50–74 (fair to good), and 75–100 (good to excellent).
Figure 3
Figure 3
Subgroup Analysis of Mean SAQ-SS Change from Baseline to 12 Months. *Wilcoxon rank-sum test.
See this image and copyright information in PMC

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